MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT LINK; BLOOD GLUCOSE METER

Model Number	6203
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's age and weight were not provided.The customer did not provide the event date.Therefore, the date customer informed about the event was captured as event date.The model # was not provided.
Event or Problem Description
The customer reported that one of her blood glucose readings was not stored in the memory of the contour next link meter.There was no allegation of an adverse event.The customer disconnected the call.Therefore, the customer could not be advised to return the device for evaluation and replacement device could not be offered.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, a device history record was reviewed for the suspected contour next link meter and no manufacturing anomalies were found.Section h4 of the initial report indicated the device manufacture date for the suspected contour next link serial # (b)(6) as 10-nov-2015.The correct device manufacture date is 11-nov-2015.

• Brand Name: CONTOUR NEXT LINK
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10119007
• Report Number: 1810909-2020-00289
• Device Sequence Number: 3467887
• Product Code: NBW
• UDI-Device Identifier: 00301936203016
• UDI-Public: 00301936203016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6203
• Device Catalogue Number: 6203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR